Status:
RECRUITING
PBM as Strategy to CABG Anemic Patients Bypass Graft (CABG)
Lead Sponsor:
Federal University of São Paulo
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions:
Anemia
Coronary Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Anemia poses risks during coronary artery bypass grafting (CABG), increasing complications and mortality rates. Blood transfusions in cardiac surgery have negative outcomes, prompting the use of eryth...
Detailed Description
Anemia increases the risk of postoperative complications and mortality in patients undergoing coronary artery bypass grafting (CABG). In addition, the use of blood transfusions during cardiac surgery ...
Eligibility Criteria
Inclusion
- Eletive surgery;
- Only CABG as procedure;
- Off pump CABG candidate.
Exclusion
- Age \> 80 years;
- Chronic dialytic kidney disease;
- Chronic rheumatologic disease;
- Men with Hb levels \> 13 g/dl and \< 8g/dl;
- Women with Hb levels \> 12 g/dl and \< 8g/dl;
- Presence of another heart disease requiring surgical intervention;
- Presence of hepatic insufficiency;
- Presence of any implantable electronic cardiac device in any cardiac chambers;
- Pregnancy;
- Diagnosis of malignant neoplasia;
- Thrombophilias;
- Need for Erythropoietin treatment due to any other disease.
- Recent ischemic event (\< 3 months).
- Ejection fraction \<30%.
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06542393
Start Date
June 1 2024
End Date
June 1 2026
Last Update
August 7 2024
Active Locations (1)
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1
Leonardo Ohashi
São Paulo, São Paulo, Brazil, 04024-002